Kornimate/medical-research-clean huggingface dataset:
bli (blue light imaging) for the histological characterization of colorectal polyps

Conditions: Adenoma Colon

Summary: the accuracy of real-time histology prediction (hyperplastic vs. adenomas) of colonic polyps using white light high-definition endoscopes is suboptimal. blue laser imaging (bli) is a new system for image-enhanced endoscopy using laser light, that is incorporated in the last generation fuji high- definition videocolonscopes eluxeo. blue laser imaging (bli) utilizes two monochromatic lasers instead of xenon light: a 410 nm laser visualizes vascular microarchitecture, similar to narrow band imaging, and a 450 nm laser provides white light by excitation.this system should enhance the microvascular pattern of superficial lesions, making the histological prediction easier. aim of the study is to compare the accuracy of white light and bli systems in real-time histology prediction of colonic polyps. for this purpose all colonscopies will be performed in a standard fashion using white light. when a polyps \<10mm in size will be identified, patients will be randomized in two groups. in the group 1 (white light grroup), all polyps \<10mm will be evaluated with white light and prediction of histology (hyperplastic versus adenomatous) will be made by means of white light. in the group 2 (bli group) , all polyps \<10mm in size will be evaluated with bli and scored as hyperplastic (type 1) or adenomatous (type 2) by applying the nice (narrow-band imaging international colorectal endoscopic) classification, indicating color/vessel/surface pattern. the level of endoscopist's confidence in predicting histology (high or low confidence) for any polyp will be also recorded. diagnostic performances of the endoscopists (sensitivity, specificity, positive and negative predictive values) will be calculated comparing endoscopist's prediction and pathology report, considered as reference standard in both study groups in order to evaluate the accuracy of real-time histology prediction by using bli or white light.


Eligibility criteria:
inclusion criteria: * all outpatients referred for colonoscopy exclusion criteria: * inadequatete bowel preparation (boston bowel preparation scale (bbps) \< 2 in one colonic segment) * previous colonic resection * inflammatory bowel disease * ereditary polyposic syndromes * patients on antithrombotics precluding polyp resection * absence of informed consent * inpatients or patients undergoing urgent colonscopy
strategies for enhancing mucosal immunity to influenza vaccine

Conditions: Mucosal Immunity

Summary: the purpose of this study is to determine the safety and effectiveness of the influenza vaccine when administered nasally and intra-muscular (a "shot" of medicine given into a muscle). the investigators will measure the systemic (through out the body) and mucosal immune responses (how your body recognizes and defends itself against bacteria) to nasally administered influenza vaccine, and determine if nasal immunization results in immunity (your body's ability to avoid infections) within multiple mucosal compartments (ocular (eye), oral and reproductive), in comparison with intramuscular administration and placebo (inactive substance given in the same form as the active drug).


Eligibility criteria:
inclusion criteria: * healthy men and women ages 18-50 years * non-smokers (defined as no tobacco use within the last 12 months and less than 10 pack-year lifetime tobacco use) * willing and able to provide written informed consent * able to speak and understand english * women of childbearing potential must have a negative serum pregnancy test. exclusion criteria: * influenza vaccination within 6 months prior to screening date * symptoms of respiratory infection during the 14 days prior to screening * temperature \>38.3o c during the period spanning 72 hours prior to screening and the time of immunization. * history of allergy to egg, influenza vaccine or vaccine ingredients * history of guillain-barre syndrome * history of bell's palsy * tonsillectomy, adenoidectomy or prior surgery to the paranasal sinus cavity. * physician diagnosis of or personal history of allergic or chronic rhinitis * physician diagnosis of or personal history of asthma * acute sinusitis within 30 days prior to screening * use of antibiotics within 14 days prior to screening * requirement for use of nasal corticosteroids for the period beginning 30 days prior to screening through final study visit * requirement for use of antihistamines (systemic, intranasal or intraocular) for the period beginning 72 hours prior to screening through final study visit * use of immunomodulating drugs or systemic corticosteroids within 6 months prior to screening (includes but is not limited to azathioprine, methotrexate, mycophenolate mofetil, tumor necrosis factor inhibitors, cyclosporine, tacrolimus) * past or present history of allergen immunotherapy to within the last 10 years. * students or employees who are under direct supervision by any of the investigators in this protocol are not eligible to participate. * subjects who abuse alcohol or illicit substances will be excluded. * other medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements. * nursing mothers. * other investigational medication use within 30 days of screening.

Keywords: vaccination mucosal immunity nasal immunization
enhancing plasticity in stroke patients with severe motor deficit

Conditions: Stroke; Cerebrovascular Accident

Summary: this study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training, to improve hand motor function in poorly recovered stroke patients. the central hypothesis is that stroke patients with severe motor deficit receiving hand nerve stimulation and intensive task-oriented therapy will have improved motor function compared to patients receiving sham nerve stimulation and task-oriented therapy.

stroke is one of the most devastating and prevalent diseases, but efforts to limit the amount of tissue damaged in the acute phase have been disappointing, highlighting the need for effective therapeutic interventions after neurologic damage has occurred. data from animal and human models have suggested that sensory input plays an important role in motor output, possibly by influencing cortical plasticity. however, in spite of the advances to date, little is known about the extent to which sensory input in the form of peripheral nerve stimulation can be successfully combined to physical training especially in poorly recovered stroke patients. this study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training, to improve hand motor function in stroke patients with severe motor deficit. the central hypothesis is that stroke patients with severe motor deficit receiving hand nerve stimulation and intensive task-oriented therapy will have improved motor function compared to patients receiving sham nerve stimulation and task-oriented therapy, and the degree of this behaviorally-measured effect will correlate with the neurophysiological effect measured by transcranial magnetic stimulation.

Eligibility criteria:
inclusion criteria: * chronic stroke patients * single stroke * chronic (more than 12 months after from stroke) * at least 21 years old, but there is no upper age range for this project. * participants not able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°. exclusion criteria: * history of carpal tunnel syndrome and conditions that commonly cause peripheral neuropathy, including diabetes, uremia, or associated nutritional deficiencies * history of head injury with loss of consciousness, severe alcohol or drug abuse, psychiatric illness * within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery * cognitive deficit severe enough to preclude informed consent * positive pregnancy test or being of childbearing age and not using appropriate contraception * participants with history of untreated depression.

Keywords: motor recovery neuroplasticity chronic human sensory
safety and efficacy of the therapeutic vaccine gi-5005 versus placebo for the treatment of chronic hepatitis c infection

Conditions: Hepatitis C

Summary: the gi-5005 therapeutic vaccine or placebo will be injected under the skin of hepatitis c virus (hcv) subjects. patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections.


Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis c virus infection including treatment naive subjects as well as subjects who are partial responders and relapsers to prior interferon therapy * \>18 years of age * negative skin test for hypersensitivity to saccharomyces cerevisiae. exclusion criteria: * non-responders to previous interferon treatments * cirrhosis * hcv treatment within 3 months * hepatitis b infection * hiv infection

Keywords: hepatitis hcv vaccine hepatitis c infection
clinical trial evaluating lumateperone monotherapy in the treatment of bipolar depression or major depressive disorder

Conditions: Bipolar Depression; Major Depressive Disorder

Summary: this is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with bipolar i or bipolar ii disorder (bipolar depression) or major depressive disorder (mdd) who also meet the diagnostic and statistical manual of mental disorder, 5th edition (dsm-5) criteria for mixed-features. the study consists of a screening period, a double-blind treatment period, and a safety follow-up period.


Eligibility criteria:
major inclusion criteria: * male or female subjects of any race, ages 18-75 inclusive * meets the diagnostic and statistical manual of mental disorder, 5th edition (dsm 5) criteria for bipolar i or bipolar ii disorder or mdd * the start of the current major depressive episode is at least 2 weeks but no more than 6 months prior to the screening (visit 1) * has at least moderate severity of illness, as measured by a rater-administered madrs total score ≥ 24 and corresponding to a cgi s score of ≥ 4 at screening (visit 1) and baseline (visit 2) * the patient meets the dsm-5 criteria for mixed-features specific to the bipolar i or ii diagnosis or mdd diagnosis * current major depressive episode is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning * able to provide written informed consent major exclusion criteria: * any female subject who is pregnant or breast-feeding * any subject judged to be medically inappropriate for study participation * the patient has a significant risk for suicidal behavior * the patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma

Keywords: mixed features
interest of using deep learning algorithm for otosclerosis detection on temporal bone high resolution ct

Conditions: Otosclerosis

Summary: otosclerosis is a relatively frequent pathology, of multifactorial origin with genetic and hormonal part, predominantly in women. this disease causes a disorder of the bone metabolism of the middle and inner ear, responsible for a progressive deafness, which can become severe. several elements are necessary to make the diagnosis of otosclerosis: the clinical examination and questioning, the audiometric assessment, and finally the temporal bone ct. the ct scan allows to detect foci of otosclerosis within the bone of the middle or inner ear. this diagnosis is sometimes difficult and requires interpretation by a trained radiologist. the investigators would like to evaluate the ability of a deep learning algorithm to detect these foci of otosclerosis, and to compare its diagnostic performance with a trained radiologist.

otosclerosis is a relatively frequent pathology, of multifactorial origin with genetic and hormonal part, predominantly in women. this disease causes a disorder of the bone metabolism of the middle and inner ear, responsible for a progressive deafness, which can become severe. several elements are necessary to make the diagnosis of otosclerosis: the clinical examination and questioning, the audiometric assessment, and finally the temporal bone ct. the ct scan allows to detect foci of otosclerosis within the bone of the middle or inner ear. this diagnosis is sometimes difficult and requires interpretation by a trained radiologist. the investigators would like to evaluate the ability of a deep learning algorithm to detect these foci of otosclerosis, and to compare its diagnostic performance with a trained radiologist.

Eligibility criteria:
* inclusion criteria \* : * age over 18 * high resolution temporal bone ct scan available for analysis * for the "case" group : surgical confirmation of positive diagnosis for otosclerosis * for the "control" group : a first radiological analysis in favor of a normal temporal bone ct scanner and an initial radiologic report considered normal as well * exclusion criteria \* : * age under 18 * no high resolution temporal bone ct scan available for analysis * unwillingness to participate in the study

Keywords: otosclerosis ia deep learning temporal bone ct
stem cells treatment of complex crohn's anal fistula

Conditions: Anal Fistula; Crohn Disease

Summary: a pilot study to investigate the safety and feasibility of stem cells treatment of complex anal fistula in patients with crohn's disease.

stem cells therapy in the management of soft tissue healing has been shown to be safe and feasible with encouraging short-term results both for crypto glandular and crohns anal fistula. the long-term results are still insufficient but based on only a few studies conducted with small patient series and various techniques and type of stem cells. in the present study the patient's own adipose tissue derived regenerative cells (adrcs) will be used. traditionally the stem cells are injected into the fistula tract; however survival and retaining the stem cells in the fistula tract is problematic. alternatively, one may apply stem cells enriched fatty tissue around and into the fistula tract. the aim of this project is to develop a method for treatment of patients with crohns fistula. the results of conventional surgery are disappointing and followed by a high degree of recurrence and complications.

Eligibility criteria:
inclusion criteria: * patients with crohn's anal fistulas and\> 18 yrs old. exclusion criteria: * signs of suppuration around the fistula * active intestinal crohn disease not in remission * malignancy within 5 years * previous radiotherapy of the abdomen and pelvis * bmi under 18.5 * coagulopathy * fistula with side branches * low anal fistula * verified syphilis, hiv, or hepatitis on screening test.

Keywords: stem cells therapy
effectiveness of acupuncture for asthma

Conditions: Asthma

Summary: what is the trend of changes in asthmatic patients' daily peak expiratory flow (pef) variability, pulmonary function, and quality of life (qol) with acupuncture treatment on specific acupoints (cv22 and bilateral lu5, st40, bl13, exb1) compared with minimal acupuncture treatment (sham control group) on non-acupoints, and no acupuncture treatment (waiting list control group)?


Eligibility criteria:
inclusion criteria: * aged 19-70 years * at least 12% improvement in forced expiratory volume in one second (fev1)after the administration of short acting beta2 agonist. * at least one typical asthmatic symptom * using more than one routine anti-asthmatic medicine exclusion criteria: * acupuncture for asthma within 12 months of the study * emergency department visit within one month of the study * hospitalization for asthma within three months of the study * severe upper respiratory tract infections within six weeks of the study * systemic infections, cancers, autoimmune disorders, cardiac failures, myofacial infarcts,angina pectoris, renal failures or hepato-biliary diseases * smoke more than ten cigarettes per day

Keywords: asthma acupuncture pulmonary function quality of life
a study to learn about the medicine (pf-07321332 or nirmatrelvir/ritonavir) in healthy lactating women

Conditions: Healthy Participants

Summary: the main purpose of this study is to measure the level of active ingredient of the study medicine (nirmatrelvir) that is secreted in human breast milk when it is given to healthy breastfeeding women. the study medicine consists of two medicines, nirmatrelvir and ritonavir. we are seeking female participants who are: * actively breast-feeding (lactating) at least 12 weeks postpartum; * age between 18 to 55 years and not currently pregnant; * have a body mass index (bmi): 17.5 kg/m2; and a total body weight \>50 kg (110 lb). participants will take the study medicine by mouth for a total of 3 times over 2 days (2 morning doses and 1 evening dose) at the study clinic. we will periodically collect breast milk from day 2 to 4 to measure the level of nirmatrelvir and ritonavir in it. a safety follow up call will be conducted around 28-35 days from the last dose to monitor any reactions participants may have to the study medicine.


Eligibility criteria:
inclusion criteria: * healthy lactating females who are actively breast-feeding or expressing breast milk, at least 12 weeks post-partum and not currently pregnant between 18 and 55 years old * body mass index (bmi): 17.5 kg/m2; and a total body weight \>50 kg (110 lb) * infants of women enrolled in the study must be able to feed successfully from a bottle or other age-appropriate alternative feeding method prior to the start of the study and must be able to tolerate infant formula if the mother does not have a supply of stored breast milk sufficient to cover the duration of the study * participants must be willing to temporarily discontinue breast feeding their infants for a total of 4.5 days (108 hours) * participants must be willing to regularly pump breasts throughout the study and express milk according to a schedule designed to maintain lactation throughout the study period exclusion criteria: * positive test result (rt-pcr) for sars-cov-2 infection at the time of screening or day -1 * evidence or history of clinically significant findings * history of febrile illness or mastitis within 5 days prior to the first dose of study medication * participants who have received a covid-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a covid-19 vaccine at any time during the study confinement period * history of hiv infection, hepatitis b, or hepatitis c; positive testing for hiv, hbsag, or hcvab. hepatitis b vaccination is allowed * abnormal vital signs such as blood pressure, 12-lead electrocardiogram * history of alcohol abuse and/or illicit drug use, tobacco use in excess of 5 cigarettes/day or 2 chews/day * blood donation within 60 days

Keywords: severe acute respiratory syndrome coronavirus 2 (sars-cov-2) lactation covid-19 breastfeeding protease inhibitor
effect of a wechat platform-based management intervention on blood pressure control

Conditions: Hypertension

Summary: wechat is the largest and most popular social media platform in china, in this study, investigators will evaluate the use of management program delivered via wechat platform in patients with hypertension.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years with confirmed diagnosis of hypertension * office systolic blood pressure (sbp)≥140 mmhg and/or diastolic blood pressure (dbp)≥90 mmhg, or ambulatory blood pressure monitoring (abpm) indicating 24- hour sbp ≥130 mmhg and/or dbp ≥80 mmhg and/or daytime sbp ≥135 mmhg and/or dbp ≥85 mmhg and/or nocturnal sbp ≥120 mmhg and/or dbp ≥70 mmhg. * patients have smart phone and often use wechat to communicate with others (including written interaction) * patients are willing and able to give informed consent for participation in the trial exclusion criteria: * secondary hypertension * hypertensive emergency: defined as severe elevations in bp (sbp ≥180 mmhg and/or dbp≥120mmhg) associated with evidence of new or worsening target organ damage, including hypertensive encephalopathy, intracranial hemorrhage, cerebral hemorrhage, subarachnoid hemorrhage, cerebral infarction, heart failure, acute coronary syndrome (unstable angina, acute myocardial infarction), aortic dissection, perioperative hypertension, preeclampsia, and eclampsia * refractory hypertension: defined as failure to control bp despite lifestyle changes and use of at least 5 antihypertensive agents of different classes, including a thiazide-type diuretic and a mineralocorticoid receptor antagonist * pregnancy or lactation or having pregnancy plan during the study period * life expectancy less than 1 year * participation in another clinical study or clinical trial in the 3 months prior to the confirmation of eligibility or current user of wechat platform provided by hypertension center of the first affiliated hospital of wenzhou medical university
safety and efficacy of systemic chemotherapy plus pd-1 inhibitor in combination with bevacizumab in gastric cancer with peritoneal metastasis

Conditions: Gastric Cancer Peritoneal Metastases

Summary: it is an open label, phase ii study involved receiving albumin-bound paclitaxel plus s-1 combined with sintilimab and bevacizumab in patients with gastric cancer peritoneal metastasis.


Eligibility criteria:
inclusion criteria: * 18 to 75 years patients histologically or cytologically confirmed the presence of gc or gastroesophageal junction tumor with pm (her2 negative). the ecog performance status is 0-1 and the expected survival time is more than 3 months. did not receive any therapy for gc within the last six months (chemotherapy, radiation therapy, or both). exclusion criteria: * principal exclusion criteria: the obstruction of the cardia and pylorus affects the patient\&#39;s eating and gastric emptying, or has difficulty swallowing tablets. her2-positive gc and gastroesophageal junction tumors. subject with other malignancies, except for non-melanoma skin cancer or in-situ cervical carcinoma under adequate treatment, or other treated malignancies without evidence of recurrence for 5 years. previously received the following therapies: anti-pd-1, anti-pd-l1 or anti-pd-l2 drugs or drugs that stimulate or co-inhibit t cell receptors (eg, ctla-4, ox-40, cd137). received systemic treatment with chinese medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) with anti-tumor indications within 2 weeks before the first administration; active autoimmune disease requiring systemic therapy (eg, disease-modifying drugs, glucocorticoids, or immunosuppressants) occurred within 2 years prior to first dose; replacement therapy (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy.